LIKEST Study: Lipocet® in Adults With Primary Knee Osteoarthritis Grade 3-4

After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Lipocet ® (once a day, 10 ml corresponding to 1500 mg of Cetylated fatty acids) or placebo (once a day, 10 ml) during 60 days of treatment.

Inclusion criteria

• Signed Patient Information Sheet and Informed Consent Form
• Patients with primary osteoarthritis classified according to ACR/EULAR criteria
• Men or women aged ≥ 40 and ≤80 years
• A disease severity grade 3 or 4 according to the Kellgren-Lawrence classification:

• grade 0 (none): definite absence of x-ray changes of osteoarthritis
• grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping
• grade 2 (minimal): definite osteophytes and possible joint space narrowing
• grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends
• grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends
• Patients who are candidates for knee replacements can be included (this criterion is not mandatory)
• Patients who mark the pain ≥ 4 cm on a VAS
• Patients who are willing or able to follow doctor's instructions
• Patients not participating in other clinical trials within 30 days before the screening
• Patients who have received sufficient explanation for this clinical trial and agreed to participate

Exclusion criteria

• BMI > 32
• Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
• Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
• Patients with major infections in the observation period
• Renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
• Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal